Hidroxizinum Aflofarm

Package Leaflet: Information for the Patient

Hydroxyzinum Aflofarm, 2 mg/mL, Syrup

Hydroxyzine Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, you may need to read it again.
• -If you have any further questions, ask your doctor or pharmacist.
• -This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Hydroxyzinum Aflofarm and what is it used for
• 2. Important information before taking Hydroxyzinum Aflofarm
• 3. How to take Hydroxyzinum Aflofarm
• 4. Possible side effects
• 5. How to store Hydroxyzinum Aflofarm
• 6. Contents of the pack and other information

1. What is Hydroxyzinum Aflofarm and what is it used for

Hydroxyzinum Aflofarm is a medicine with anxiolytic, sedative, and antipruritic effects. It also has antihistamine (anti-allergic), antiemetic, spasmolytic (reduces smooth muscle tension in the digestive tract), and analgesic properties.

Indications:

• Symptomatic treatment of anxiety in adults;
• Symptomatic treatment of itching;
• Pre-medication before surgical procedures (pharmacological preparation of the patient for surgery).

2. Important information before taking Hydroxyzinum Aflofarm

When not to take Hydroxyzinum Aflofarm

• If you are allergic to hydroxyzine or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to cetirizine, another piperazine derivative, aminophylline, or ethylenediamine;
• If you have porphyria (a disease characterized by abnormal heme production - a component of hemoglobin);
• If you are pregnant or breastfeeding;
• If your ECG (electrocardiogram) shows heart rhythm disturbances called "QT interval prolongation";
• If you have or have had cardiovascular disease or if your heart rate is very low;
• If you have low electrolyte levels (e.g., low potassium or magnesium levels);
• If you are taking certain medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see "Hydroxyzinum Aflofarm and other medicines");
• If someone in your family has died suddenly due to heart disease.

Warnings and precautions

Before starting treatment with Hydroxyzinum Aflofarm, discuss with your doctor:

• If you have kidney problems;
• If you have liver problems;
• If you have a lowered seizure threshold (tendency to seizures);
• If you have a tendency to heart rhythm disorders (arrhythmias) or are taking anti-arrhythmic medicines (used to normalize irregular heart rhythm);
• If you have glaucoma with closed-angle glaucoma (a certain type of glaucoma - an eye disease);
• If you have urinary retention from the bladder;
• If you have paralytic ileus (lack of bowel movement);
• If you have myasthenia gravis (a disease characterized by excessive muscle weakness).

In elderly patients (over 65 years), cognitive impairment (e.g., memory, thinking, attention disorders) may occur. The medicine may affect the results of allergy tests or methacholine bronchial provocation tests, so you should not take the medicine at least 5 days before these tests. Taking Hydroxyzinum Aflofarm may be associated with an increased risk of heart rhythm disorders, which can be life-threatening. Therefore, you should tell your doctor about any heart-related disorders and about taking any other medicines, including those available without a prescription. If you experience heart symptoms such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness during treatment with Hydroxyzinum Aflofarm, seek medical attention immediately. You should also stop taking hydroxyzine.

Children

This medicine should not be given to children under 3 years of age.

Hydroxyzinum Aflofarm and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take. This includes medicines available without a prescription. Hydroxyzinum Aflofarm may affect the action of other medicines. Other medicines may affect the action of Hydroxyzinum Aflofarm. Do not take Hydroxyzinum Aflofarm if you are taking medicines used to treat:

• bacterial infections (e.g., antibiotics such as erythromycin, moxifloxacin, levofloxacin);
• fungal infections (e.g., pentamidine);
• heart disease or high blood pressure (e.g., amiodarone, quinidine, disopyramide, sotalol);
• psychoses (e.g., haloperidol);
• depression (e.g., citalopram, escitalopram);
• gastrointestinal diseases (e.g., prucalopride);
• allergies;
• malaria (e.g., mefloquine);
• cancer (e.g., toremifene, vandetanib);
• drug addiction or severe pain (methadone);

If you are taking any of the following medicines, your dose may need to be changed or treatment stopped. In particular, ask your doctor if you are taking:

• anticoagulant medicines derived from coumarin (medicines used to reduce blood clotting);
• barbiturates (medicines used to treat insomnia and epilepsy);
• sedatives;
• sleeping pills;
• meperidine (a medicine used to treat chronic pain);
• tricyclic antidepressants, monoamine oxidase inhibitors (medicines used to treat depression);
• phenytoin (a medicine used to treat epilepsy);
• betahistine (a medicine used to treat dizziness, especially of labyrinthine origin).

If you are unsure whether you are taking any of the above medicines, ask your doctor or pharmacist.

Hydroxyzinum Aflofarm with alcohol

Do not drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. The medicine should not be used during pregnancy and breastfeeding. Hydroxyzine should not be administered during childbirth.

Driving and using machines

The medicine may affect your ability to drive and use machines. Do not drive or operate machinery while taking Hydroxyzinum Aflofarm. The medicine contains sucrose, sodium benzoate (E211), propylene glycol (E1520), sodium, citral, geraniol, farnesol, linalool, citronellol, limonene

Sucrose

The medicine contains 2711 mg of sucrose in 5 mL of syrup. This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Sodium benzoate (E211)

The medicine contains 4.519 mg of sodium benzoate in 5 mL of syrup.

Propylene glycol (E1520)

The medicine contains 4.446 mg of propylene glycol in 5 mL of syrup.

Sodium

The medicine contains 3.01 mg of sodium in 5 mL of syrup. The medicine contains 30.1 mg of sodium (the main component of table salt) in 50 mL of syrup. This corresponds to 1.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Hydroxyzinum Aflofarm

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Hydroxyzinum Aflofarm should be used in the smallest effective dose. The treatment duration should be as short as possible. The medicine is taken orally.

The dosage is determined by the doctor individually, depending on the patient's response to treatment.

To dose the medicine, use the measuring cup provided with the packaging. This allows for accurate dosing.

Recommended dosage

Adults

• In symptomatic treatment of anxiety: 50 mg per day divided into 2 or 3 single doses.
• In symptomatic treatment of itching: treatment should be started with a dose of 25 mg before bedtime. If necessary, the doctor may increase the dose, administering up to 25 mg 3 or 4 times a day.
• In pre-medication before surgical procedures: 50 to 100 mg in a single dose.

In adults and children with a body weight over 40 kg, the maximum daily dose in all indications is 100 mg.

Children

• In symptomatic treatment of itching: in children from 3 to 6 years: 5 to 15 mg per day, maximum 50 mg per day in divided doses.

In children over 6 years: 15 to 25 mg per day, maximum 50 to 100 mg per day in divided doses.

• In pre-medication before surgical procedures: 0.6 mg per kilogram of body weight in a single dose.

In children with a body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day. In elderly patients (over 65 years), treatment should be started with half the recommended dose. In patients with liver and/or kidney function disorders, treatment should be started with half the recommended dose and continued with smaller doses than usual. In elderly patients, the maximum daily dose is 50 mg.

Use in children

Do not use in children under 3 years of age.

Overdose of Hydroxyzinum Aflofarm

If you have taken more than the recommended dose, contact your doctor. Excessive sedation may occur. If you have taken or administered too much Hydroxyzinum Aflofarm, seek medical attention immediately, especially if it concerns a child. In case of overdose, symptomatic treatment can be used. ECG monitoring is recommended due to the possibility of heart rhythm disorders, such as QT interval prolongation or torsade de pointes.

Missed dose of Hydroxyzinum Aflofarm

Continue taking the medicine, without increasing the next dose. Do not take a double dose to make up for a missed dose. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and seek medical attention immediately if you experience:

• Anaphylactic shock - the first symptoms may be: skin rash, facial swelling, difficulty breathing, wheezing, shortness of breath, unpalpable pulse, significantly lowered blood pressure, sweating, loss of consciousness;
• Heart rhythm disorders, such as rapid heartbeat (palpitations), difficulty breathing, loss of consciousness.

The following side effects may occur

Very common(in more than 1 in 10 patients):

• Drowsiness.

Common(in more than 1 in 100, but less than 1 in 10 patients):

• Dry mouth;
• Headache;
• Sedation, feeling of fatigue and exhaustion.

Uncommon(in more than 1 in 1000, but less than 1 in 100 patients):

• Nausea;
• Dizziness;
• Insomnia;
• Tremors, agitation;
• Confusion (disorders of consciousness, disorientation in time, place, situation, or person);
• Malaise;
• Fever.

Rare(in more than 1 in 10,000, but less than 1 in 1000 patients):

• Tachycardia (rapid heartbeat);
• Accommodation disorders of the eye (vision disorders);
• Blurred vision;
• Constipation, vomiting;
• Hypersensitivity;
• Seizures;
• Dyskinesia (uncoordinated and involuntary movements of limbs or the whole body);
• Disorientation (disorders of orientation in time, place, situation, or person);
• Hallucinations (perception of non-existent objects or people);
• Urinary retention (inability to urinate, causing strong pressure on the bladder);
• Skin inflammation, itching;
• Rash;
• Urticaria (red, itchy blisters on the skin);
• Hypotension (significantly lowered blood pressure).

Very rare(in less than 1 in 10,000 patients):

• Anaphylactic shock;
• Bronchospasm (wheezing, shortness of breath);
• Angioedema (sudden swelling of the face, limbs, or joints without itching or pain);
• Increased sweating.

Frequency not known

• Ataxia (difficulty in maintaining balance, unsteady gait);
• Disorders of blood cell production in the bone marrow with thrombocytopenia (significantly reduced platelet count);
• Coagulation disorders (increased tendency to bleeding and bruising);
• Cognitive impairment in elderly patients (see section "Warnings and precautions");
• Feeling of emptiness in the head;
• Irritability;
• Weight gain.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hydroxyzinum Aflofarm

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hydroxyzinum Aflofarm contains

• The active substance of the medicine is hydroxyzine hydrochloride. 1 mL of syrup contains 2 mg of hydroxyzine hydrochloride. The other ingredients are sodium benzoate (E211), sucrose, citric acid (E330), sodium citrate (E331), vanilla flavor AR 0345 (contains propylene glycol (E1520)), orange flavor AR1430 (contains citral, geraniol, farnesol, linalool, citronellol, limonene), purified water.

What Hydroxyzinum Aflofarm looks like and contents of the pack

The medicine is a light yellow syrup. The pack is a brown glass bottle containing 200 mL or 250 g of syrup, closed with an aluminum cap, placed in a cardboard box with a measuring cup.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, tel. (42) 22-53-100

Date of last revision of the leaflet: